BPSD (Behavioral and Psycological Symptoms of Dementia)NCT06523309
Electroacupuncture Treatment of Behavioral and Psycological Symptoms in Patients With Alzheimer's Disease
An observational study of BPSD (Behavioral and Psycological Symptoms of Dementia) and Alzheimer's Dementia, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 7 sites in China.
Trial summary
This study aims to establish a prospective case registration research platform for electroacupuncture in treating behavioral and psychological symptoms in patients with mild to moderate Alzheimer's disease, and to investigate the dose-effect relationship and cost-effectiveness of electroacupuncture for these symptoms. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- BPSD (Behavioral and Psycological Symptoms of Dementia), Alzheimer's Dementia
- What is being tested?
- Electroacupuncture treatment
- How many people
- 1,000 participants
- Where
- 7 sitesChina
- Study dates
- 30 Jul 2024to 31 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Alzheimer's disease patients with behavioral and psycological symptoms, such as apathy, depression, anxiety, delusions, hallucinations, irritability, etc.
Who may be able to join
- Meet the diagnostic criteria for AD in the NIA-AA standard;
- Clinical dementia rating scale ≤2 points;
- Accompanied by at least one psychobehavioral symptom, NPI：frequency × degree ≥1 point;
- Sign informed consent.
Who cannot join
- 1.There are contraindications for acupuncture treatment, such as the tendency of acupoint bleeding or allergy to metal
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites
Beijing United Family Rehabilitation Hospital
Beijing, Beijing Municipality, 100015
Dongmei D Li, 13717850887, 13717850887@139.com
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Rongxing R Shi, 18610153099, 2243111436@qq.com
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053
Ran Li, 010-88001454, lcgxliran@163.com
Xuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality, 100053
Aihong A Zhou, 010-83192333, zahxwh@163.com
Beijing Geriatric Hospital
Beijing, Beijing Municipality, 100095
Jihui J Lv, 13520094838, lvjihui@139.com
Fujian University of Traditional Chinese Medicine
Fuzhou, Fujian, 350122
Ying Xu, 0591-22861815, aaa8858@qq.com
The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, 150001
Li Zhang, 18646026517, 13704884351@163.com
About this study
Official title: Prospective Registry of Electroacupuncture Treatment for Patients With Different Behavioral and Psycological Symptoms of Alzheimer's Disease
This study aims to establish a prospective case registration research platform for electroacupuncture in treating behavioral and psychological symptoms in patients with mild to moderate Alzheimer's disease, and to investigate the dose-effect relationship and cost-effectiveness of electroacupuncture for these symptoms.
Read the detailed description
To establish a prospective case registration research platform aimed at treating mild to moderate Alzheimer's disease patients presenting with behavioral and psychological symptoms. This platform will document the electroacupuncture treatment process, conduct regular assessments using neuropsychiatric questionnaires (NPI) and the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change Scale (ADAS-CGIC), and compare the effects of different parameters, treatment frequency, and duration of electroacupuncture on therapeutic outcomes for various behavioral and psychological symptoms in Alzheimer's disease patients. Furthermore, it aims to investigate the influencing factors of electroacupuncture treatment for behavioral and psychological symptoms.
- Being tested
- Electroacupuncture treatment
- Medical subject headings
- Behavior, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroacupuncture treatmentOther
Electroacupuncture treatment consists of conventional acupuncture and electrical stimulation. After acupuncture, the electrical stimulation is continuously stimulated.
| Study group | Role | What they receive |
|---|---|---|
| Affective symptom group | A group of Alzheimer's patients showing emotional symptoms such as anxiety, depression, apathy, etc. Receives: Other: Electroacupuncture treatment | |
| Psychotic symptom group | A group of Alzheimer's patients showing psychotic symptoms such as delusions, hallucinations, etc. Receives: Other: Electroacupuncture treatment | |
| Hyperactivity symptom group | A group of Alzheimer's patients showing hyperactivity symptoms such as irritability, aggression, aberrant motor behaviour, etc. Receives: Other: Electroacupuncture treatment | |
| Euphoric symptom group | A group of Alzheimer's patients showing euphpric symptoms. Receives: Other: Electroacupuncture treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychiatric Inventory (NPI)
NPI is used to evaluate neuropsychiatric behavioral symptoms of dementia patients. The scale assesses the neuropsychiatric disorders of patients according to the caregiver's view of the patient's behavior and the corresponding distress felt by the patient. The scoring range of the patient evaluation scale is 0-144 points, and the scoring of the caregiver distress scale is 0-60 points, the lower the score is, the better the patient's condition is.
Measured: NPI will be performed before treatment and every month after treatment for up to 24 months
Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC)
ADCS-CGIC is a global rating of change developed to assess clinically significant change in symptoms over time in AD clinical trials. Clinicians rate patient symptoms on the ADCS-CGIC as: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), and very much worse (7) compared to baseline symptoms.
Measured: The ADCS-CGIC will be performed before treatment and every 2 month after treatment for up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start30 Jul 2024 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPSD (Behavioral and Psycological Symptoms of Dementia)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bao-Hui Jia, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Baohui Jia, Principal investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523309
- Sponsor's protocol ID
- 2024-076-KY-01
- Status last verified
- Jul 2024
- First submitted
- 19 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry of Electroacupuncture Treatment for Patients With Different Behavioral and Psycological Symptoms of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06523309
- Acronym / sponsor ID
- 2024-076-KY-01
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 30 Jul 2024 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to establish a prospective case registration research platform for electroacupuncture in treating behavioral and psychological symptoms in patients with mild to moderate Alzheimer's disease, and to investigate the dose-effect relationship and cost-effectiveness of electroacupuncture for these symptoms.
Detailed description
To establish a prospective case registration research platform aimed at treating mild to moderate Alzheimer's disease patients presenting with behavioral and psychological symptoms. This platform will document the electroacupuncture treatment process, conduct regular assessments using neuropsychiatric questionnaires (NPI) and the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change Scale (ADAS-CGIC), and compare the effects of different parameters, treatment frequency, and duration of electroacupuncture on therapeutic outcomes for various behavioral and psychological symptoms in Alzheimer's disease patients. Furthermore, it aims to investigate the influencing factors of electroacupuncture treatment for behavioral and psychological symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Affective symptom group | – | Other: Electroacupuncture treatmentA group of Alzheimer's patients showing emotional symptoms such as anxiety, depression, apathy, etc. |
| Psychotic symptom group | – | Other: Electroacupuncture treatmentA group of Alzheimer's patients showing psychotic symptoms such as delusions, hallucinations, etc. |
| Hyperactivity symptom group | – | Other: Electroacupuncture treatmentA group of Alzheimer's patients showing hyperactivity symptoms such as irritability, aggression, aberrant motor behaviour, etc. |
| Euphoric symptom group | – | Other: Electroacupuncture treatmentA group of Alzheimer's patients showing euphpric symptoms. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Alzheimer's disease patients with behavioral and psycological symptoms, such as apathy, depression, anxiety, delusions, hallucinations, irritability, etc.
Key inclusion criteria (4 listed)
- Meet the diagnostic criteria for AD in the NIA-AA standard;
- Clinical dementia rating scale ≤2 points;
- Accompanied by at least one psychobehavioral symptom, NPI：frequency × degree ≥1 point;
- Sign informed consent.
Key exclusion criteria (1 listed)
- 1.There are contraindications for acupuncture treatment, such as the tendency of acupoint bleeding or allergy to metal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electroacupuncture treatmentElectroacupuncture treatment consists of conventional acupuncture and electrical stimulation. After acupuncture, the electrical stimulation is continuously stimulated. | Other | Affective symptom group, Euphoric symptom group, Hyperactivity symptom group, Psychotic symptom group |
Primary outcome
Neuropsychiatric Inventory (NPI)
Time frame: NPI will be performed before treatment and every month after treatment for up to 24 months
NPI is used to evaluate neuropsychiatric behavioral symptoms of dementia patients. The scale assesses the neuropsychiatric disorders of patients according to the caregiver's view of the patient's behavior and the corresponding distress felt by the patient. The scoring range of the patient evaluation scale is 0-144 points, and the scoring of the caregiver distress scale is 0-60 points, the lower the score is, the better the patient's condition is.
Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC)
Time frame: The ADCS-CGIC will be performed before treatment and every 2 month after treatment for up to 24 months
ADCS-CGIC is a global rating of change developed to assess clinically significant change in symptoms over time in AD clinical trials. Clinicians rate patient symptoms on the ADCS-CGIC as: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), and very much worse (7) compared to baseline symptoms.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for BPSD (Behavioral and Psycological Symptoms of Dementia)
Recruiting
Integrative Therapeutic Programme to Regulate Expressed Emotions Among Informal Caregivers of People With Dementia
BPSD (Behavioral and Psycological Symptoms of Dementia), Expressed Emotion
Active, not recruiting
Psychosocial Intervention for Behavioral Symptoms in Hospitalized Patients With Dementia or Delirium
BPSD (Behavioral and Psycological Symptoms of Dementia)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Baohui Jia principal investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of BPSD (Behavioral and Psycological Symptoms of Dementia) and Alzheimer's Dementia, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Baohui B Jia (010-88001454, jiabaohui2504@gamyy.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychiatric Inventory (NPI) (time frame: NPI will be performed before treatment and every month after treatment for up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.